Medicine
Arcalyst 160 mg/2 mL powder for injection
Arcalyst 160 mg/2 mL powder for injection is a prescription medicine containing Rilonacept for subcutaneous use, marketed by Kiniksa Pharmaceuticals (UK), with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to…
Key facts
- Active ingredient (INN)
- Rilonacept
- Brand
- Arcalyst
- Strength
- 160 mg/2 mL
- Dosage form
- Powder for injection
- Route
- Subcutaneous
- Packs
- 1 vial, 4 vials
- Marketing authorisation holder
- Kiniksa Pharmaceuticals (UK)
- Manufacturer
- Kiniksa Pharmaceuticals (UK)
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. After reconstitution, ARCALYST may be kept at room temperature, protected from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AC04 Rilonacept
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 February 2008
- Identifiers
- RxCUI 763453, 763457DailyMed set ID ad965f38-dd22-4607-a673-2fb92f3b527aNDC 73604-914Application BLA125249
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 73604-914-01 | Kiniksa Pharmaceuticals (UK) | 18 June 2021 |
| 4 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 73604-914-04 | Kiniksa Pharmaceuticals (UK) | 24 March 2008 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Rilonacept is a prescription medicine indicated for treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older, among other approved uses. MedsAcross supplies Rilonacept for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about RilonaceptFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Arcalyst prescribing information (Kiniksa Pharmaceuticals (UK)) · U.S. National Library of Medicine, DailyMed
Need Arcalyst 160 mg/2 mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.